USP Class VI Solid Silicone Sheet
ElastaPro manufactures high-purity, platinum-cured USP Class VI solid silicone sheeting engineered for the most stringent medical, pharmaceutical, and biotechnology environments. Proudly fabricated in the USA, our specification-grade silicone elastomers feature an exceptionally low extractable profile, ensuring safe, non-reactive performance during short-term biological contact (less than 29 days).
Our advanced manufacturing capabilities allow us to produce high-consistency rubber (HCR) sheeting with precise tolerances, delivering maximum reliability for critical sealing, gasketing, and fluid-transfer processing components.
Technical Specifications & Product Capabilities
ElastaPro USP Class VI silicone sheets are formulated to meet rigorous material performance standards. Use the data profile below to match your specific engineering requirements.
Material Performance Profile
| Attribute | Specification / Capability |
| Durometer Range | 10 to 70 Shore A |
| Thickness Capabilities | 0.007” to 0.500” |
| Maximum Width | Up to 60” (1.52m) |
| Standard Profiles | Smooth / Gloss finish; Translucent or custom color-matching |
| Curing System | 100% Platinum-Cured (High-Consistency Rubber) |
| Temperature Resistance | -80°F to 450°F (-62°C to 232°C) |
Regulatory and Material Compliance
Every batch of our high-purity silicone is traceable and manufactured to meet global regulatory benchmarks:
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USP Class VI Certified (Third-party lab verified for biological reactivity)
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FDA 21 CFR 177.2600 compliant for food-contact surfaces
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ISO 10993 elements (Cytotoxicity and systemic toxicity standards)
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European Pharmacopoeia 3.1.9 compliant
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3-A Sanitary Standards compliant
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REACH and RoHS compliant
Standard Product Configurations
We maintain standard base configurations to streamline procurement, while offering extensive customization for custom dimensions, tight-tolerance slitting, and specialized durometers.
Material Selection Matrix
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ESS10HC – 10 Durometer Shore A (Ultra-soft, high-flexibility applications)
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ESS20HC – 20 Durometer Shore A
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ESS30HC – 30 Durometer Shore A
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ESS40HC – 40 Durometer Shore A (Standard seals and compliant diaphragms)
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ESS50HC – 50 Durometer Shore A
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ESS60HC – 60 Durometer Shore A
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ESS70HC – 70 Durometer Shore A (High-durometer, high-pressure gaskets)
Critical Applications
ElastaPro platinum-cured silicone sheeting is widely specified across industries where cross-contamination must be completely eliminated:
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Pharmaceutical Processing: Gaskets, sanitary seals, manifold diaphragms, and pump lines.
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Medical Device Manufacturing: Non-implantable die-cut components, cushioning pads, and enclosure seals.
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Biotechnology Platforms: Single-use processing assemblies, filtration gaskets, and validation system seals.
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Laboratory Operations: High-purity laboratory matting, vessel closures, and peristaltic pump backup surfaces.
Frequently Asked Questions
How do you ensure your silicone sheets meet USP Class VI compliance?
Our solid silicone sheets undergo rigorous testing by a third-party laboratory to verify compliance with United States Pharmacopeia (USP) biological reactivity standards. This involves in vivo testing—including systemic injection, intracutaneous, and implantation tests—to confirm that our platinum-cured materials elicit no adverse biological reaction when in contact with live tissue or pharmaceutical mediums.
What sterilization methods are compatible with ElastaPro USP Class VI silicone?
ElastaPro’s medical-grade silicone sheeting maintains its physical properties and structural integrity across standard sterilization protocols. It is fully compatible with steam autoclaving, ethylene oxide (EtO) gas, and gamma radiation. Because of the inherent thermal stability of our platinum-cured compounds, the material will not degrade or leach under repeated sterilization cycles.
Is this material suitable for long-term medical implantation?
No. ElastaPro USP Class VI silicone sheets are engineered and certified for medical, pharmaceutical, and biotechnology processing equipment, as well as short-term biological contact (typically defined as less than 29 days). They are not intended, tested, or approved for permanent or long-term surgical implantation inside the human body.
What additional regulatory standards do these silicone sheets satisfy?
Beyond USP Class VI certification, our solid silicone sheeting is manufactured using ingredients that comply with FDA 21 CFR 177.2600 regulations for food-contact surfaces. Additionally, our formulations meet the criteria for 3-A Sanitary Standards, European Pharmacopoeia 3.1.9 compliance, and parts of ISO 10993 biological evaluation guidelines, ensuring absolute purity for critical processing paths.
Request Additional Information & Pricing
Ready to integrate ElastaPro specification-grade sheeting into your production lineup? Contact us today for pricing, custom dimensions, roll capabilities, or to request material sample sheets for engineering validation.
